E-LEARNING | GCP | Risk Assessment & Controls
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RBQM E-Learning

GCP / Risk Controls / E8(R1)

We’ve created the RBQM training materials your staff need, saving you time, effort, and money. Simple and engaging, our one-hour e-learning modules, including interactive quizzes, testing, and certification, make administering all-staff training simple and efficient.

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We have three modules that cover the essential information you need. They are Good Clinical Practice (GCP), Risk Assessment & Controls, and ICH E8(R1).

About our e-learning modules

Front screen ICH E6 (R2) Good Clinical Practice GCP e-learning training course Risk Based Monitoring Risk-Based Quality Management

All three modules use modern graphic design and an easy-to-use interface that allows learners to focus on the content.  The animated, friendly and fun approach keeps learners interested and engaged, making learning easy.

Importance of ICH E6 (R2) Clinical Trial Study Risk Assessment and Control e-learning training course Risk Based Monitoring Risk-Based Quality Management
Menu screen ICH E6 (R2) Good Clinical Practice GCP e-learning training course Risk Based Monitoring Risk-Based Quality Management
Visual Menu Map Navigation ICH E6 (R2) Clinical Trial Study Risk Assessment and Control e-learning training course Risk Based Monitoring Risk-Based Quality Management

The modules can be delivered through your Learning Management System (LMS), or ours. Our LMS tracks who has taken the course, how long they took, the questions they got right (and wrong) and their pass percentage. And it automatically produces a certificate to prove the learner has passed the course. 

And of course, the training is scalable. We can deal with anything from 1 to 100,000 users.

E-learning Module - ICH E8(R1)
Learning Objectives

  • Describe the general principles in E8(R1) General Considerations for Clinical Studies

  • Explain  Quality by Design and Critical to Quality Factors

  • Overview of Clinical Study Design, Planning, Conduct, Analysis and Reporting

  • List types of clinical studies performed during the product lifecycle

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Course Content

  • Efficacy Guidelines

  • Designing Quality into Clinical Studies

  • Drug Development Planning

  • Design Elements and Data Sources

  • Study Conduct, Monitoring & Reporting

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E8(R1)
E-learning Module - Good Clinical Practice (GCP)
Learning Objectives

  • Specify the ICH GCP principles that apply to your role

  • Identify key ICH GCP responsibilities for the roles of IRB/IEC, sponsor and investigator

  • Describe the importance of RBQM in clinical trials

Meet the Guide ICH E6 (R2) Good Clinical Practice GCP e-learning training course Risk Based Monitoring Risk-Based Quality Management
Principles of GCP ICH E6 (R2) Good Clinical Practice GCP e-learning training course Risk Based Monitoring Risk-Based Quality Management
Course Content

  • GCP Principles

  • RBQM

  • IRB/IEC

  • Sponsor

  • Investigators

  • Essential Documents

  • Summary and Quiz

What is GCP ICH E6 (R2) Good Clinical Practice GCP e-learning training course Risk Based Monitoring Risk-Based Quality Management
GCP
Risk
E-learning Module - Risk Assessment and Controls
Learning Objectives

  • Define RBQM and its importance in the design and conduct of clinical trials

  • Determine critical data and processes

  • Identify and evaluate risks

  • Establish when to control risks and what to consider in risk controls

Meet the guide ICH E6 (R2) Clinical Trial Study Risk Assessment and Control e-learning training course Risk Based Monitoring Risk-Based Quality Management
Study Quality ICH E6 (R2) Clinical Trial Study Risk Assessment and Control e-learning training course Risk Based Monitoring Risk-Based Quality Management
Course Content

  • Risk: The basics

  • Critical Variables

  • Identification and evaluation of Risks

  • Risk Controls

  • Summary and Quiz

Regulatory Background ICH E6 (R2) E8 Clinical Trial Study Risk Assessment and Control e-learning training course Risk Based Monitoring Risk-Based Quality Management
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